NCT02253862已完成1 期
Assessment of Single-dose Oral Tadalafil Pharmacokinetic Characteristics When Simultaneously Co-administered With Single-dose and Steady-state Tipranavir/Ritonavir 500 mg/200 mg to Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Maximum Plasma Concentration (Cmax) for Tadalafil
研究概览
简要总结
Study to assess the effects of single-dose and steady-state tipranavir/ritonavir 500 mg/200 mg on the single-dose pharmacokinetics of tadalafil 10 mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Healthy male subjects aged between 18 years and 55 years inclusive
- •Weighing at least 40 kg
- •Volunteers must be hospitalized on day of pharmacokinetic assessments for each regimen
- •Volunteers must be willing to complete all study-related activities
- •Each volunteer must have a valid social security regimen
- •Each volunteer must have acceptable medical history, physical examination and laboratory test
- •Volunteers with negative HIV serology
排除标准
- •History or presence of allergy to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. (If heparin is used during pharmacokinetic (PK) sampling, subjects with a history of sensibility to heparin or heparin-induced thrombocytopenia should not be enrolled)
- •Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders
- •Known elevated liver enzymes in past clinical trials with any compound (experimental or marketed)
- •Clinically relevant laboratory abnormalities and all abnormal laboratory values >Grade 1, based on the Division of AIDS Grading Scale
- •Subjects with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering tipranavir, ritonavir or tadalafil to the subject
- •Volunteers who are using any form of organic nitrate, either regularly and/or intermittently (contraindication to use tadalafil)
- •Hypersensitivity to tadalafil, tipranavir, ritonavir or their excipients
- •Concurrent treatment with other experimental compounds
- •Inadequate venous access
- •Contraindications to tadalafil: Volunteers with mild or moderate hepatic impairment, Renal insufficiency or Cardiovascular disease (patients with a myocardial infarction within the last 90 days, unstable angina or angina occurring during sexual intercourse, patients with New York Heart Association Class 2 or greater heart failure in the last 6 months, patients with uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension (>170/100 mm Hg), and patients with a stroke within the last 6 months)
- •Clinically unacceptable result at the screening physical examination
- •Use of investigational medications within 30 days before study entry
- •Patients hospitalized in a medical or social establishment, for any other reason than research
- •People deprived of judicial or administrative freedom.
研究组 & 干预措施
Sequential treatment
Experimental
干预措施: Tadalafil (Drug)
Sequential treatment
Experimental
干预措施: Tipranavir (Drug)
Sequential treatment
Experimental
干预措施: Ritonavir (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) for Tadalafil
时间窗: up to 72 hours after drug administration
AUC0-∞ for Tadalafil
时间窗: up to 72 hours after drug administration
Area Under Plasma Concentration-time Curve (AUC0-72h) for Tadalafil
时间窗: up to 72 hours after drug administration
Plasma Concentration (Cp12h) for Tadalafil
时间窗: 12 hours after drug administration
次要结局
- Total body clearance (Cl/F)(up to 72 hours after drug administration)
- Volume of distribution,(up to 72 hours after drug administration)
- AUC0-12hTipranavir and Ritonavir(12 hours after drug administration)
- Time of Maximum Concentration(up to 72 hours after drug administration)
- Number of subjects with adverse events(up to 42 days)
- Cmax for Tipranavir and Ritonavir(up to 12 hours after drug administration)
- Elimination half-life (t1/2)(up to 72 hours after drug administration)
- Cp12 for Tipranavir and Ritonavir(12 hours after drug administration)
研究者
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